The following data is part of a premarket notification filed by Hasomed Gmbh with the FDA for Rehastim & Rehamove.
Device ID | K073237 |
510k Number | K073237 |
Device Name: | REHASTIM & REHAMOVE |
Classification | Stimulator, Neuromuscular, External Functional |
Applicant | HASOMED GMBH PAUL-ECKE-STRASSE 1 Magdeburg, DE 39114 |
Contact | Matthias Weber |
Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
Product Code | GZI |
CFR Regulation Number | 882.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-11-16 |
Decision Date | 2007-12-27 |
Summary: | summary |